According to the Spanish Society of Neurology (SEN), between 20 and 48% of the adult population suffers at some point from difficulty starting or maintaining the floor. Similarly, in at least 10% of cases it is due to some chronic and severe sleep disorder.
“Sleep is a physiological process of vital importance for the comprehensive health of human beings, for the survival of the individual and for the proper functioning of the nervous system. If we cannot sleep well, quality of life is reduced, the risk of hypertension increases and, therefore, of suffering a cerebrovascular accident, and other diseases that we seem can be aggravated.But in addition our cognitive functions are affected: concentration and attention capacity decrease, reaction time increases, memory failures can occur , sudden mood swings and alterations in the decision-making process, learning problems,” says Dr. Hernando Pérez, Coordinator of the Sleep and Wake Disorders Study Group of the Spanish Society of Neurology.
To date, patients with chronic insomnia have not had specific treatments available to treat this disorder, and the treatments that are given for it, such as lorazepam or diazepam, carry notable side effects, such as drowsiness the next day or dependency.
Quviviq Trade Authorization
A few days ago, the marketing authorization for daridorexant, whose trade name is ‘Quviviq’, for the treatment of adult patients with chronic insomnia.
Daridorexant works through a novel mechanism of action that, instead of inducing sleep through extensive inhibition of brain activity, only blocks the activation of orexin1 receptors. Thus, it reduces the trigger for wakefulness and allows sleep to occur, keeping its structure intact in all its phases1.
Fewer side effects
Dr. Diego García-Borreguero, specialist in Neurology and Psychiatry, international medical director of the Sleep Research Institute and one of the Spanish researchers in the trial program with this molecule, comments that “daridorexant marks a before and after in the treatment of chronic insomnia for various reasons”.
In the first place, because it is the first treatment approved in Europe and that is specifically developed to treat chronic insomnia, a disease that affects a significant part of the population and that, until now, lacked adequate treatment. Second, daridorexant, in addition to improving sleep parameters, keeps the person’s functional capacity intact the next day, reducing the impact of insomnia on quality of life.
Lastly, this drug has a radically new mechanism of action that has proven not to generate dependency or tolerance in clinical trials, in which the drug was administered for 12 months, which makes it possible to adjust the timing of treatment more appropriately. and safe for the patient.
“This aspect is truly revolutionary, since the drugs we currently have were developed for treatments of no more than 4 weeks due to their safety profile, which did not allow them to adequately treat cases of chronic insomnia”, he points out.
The EMA’s decision is based on the strong results of phase III studies of daridorexant recently published in the journal . These results demonstrated that, at the recommended dose, daridorexant improves sleep onset, maintenance, and self-reported subjective total sleep time in adult patients with chronic insomnia.
The recommended dose of daridorexant is one 50 mg tablet per night, orally, taken 30 minutes before bedtime1. In some cases, such as patients with moderate hepatic impairment or those taking moderate CYP3A4 inhibitors, the recommended dose is 25 mg per night.
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